TIDMSNG
RNS Number : 6172X
Synairgen plc
27 April 2023
Synairgen plc
('Synairgen' or the 'Company')
Results for the year ended 31 December 2022
Southampton, UK - 27 April 2023: Synairgen plc (LSE: SNG), the
respiratory company developing SNG001, an investigational
formulation for inhalation containing the broad-spectrum antiviral
protein interferon beta, today announces its preliminary statement
of audited results for the year ended 31 December 2022.
Highlights (including post period-end)
Operational
-- Completed further analysis of data accumulated from the more
than 750 patients dosed to date with SNG001. Findings included:
o Development of stratification criteria to target specific
populations in future trials;
o SNG001 reduced the risk of several recognised Long COVID
symptoms;
o Evidence of accelerated viral clearance of rhinovirus from the
lung in COPD patients; and
o Further demonstration of the well-tolerated safety profile of
SNG001.
-- Announced data from the US NIH-led ACTIV-2 Phase 2 trial for
SNG001 in COVID-19 which showed an encouraging reduction in
hospitalisation with SNG001 versus placebo in home-based
patients.
-- Published data from the Phase 3 SPRINTER trial for SNG001 in
hospitalised COVID-19 in the European Respiratory Journal Open
Research in December 2022. Data from the trial, which did not meet
primary or key secondary endpoints, included the observation of an
encouraging signal in the reduction in progression to severe
disease or death for patients treated with SNG001.
-- Gained a deeper understanding of the extent of the mechanism
of action of SNG001 as a host directed, variant-agnostic antiviral
agent:
o Potent antiviral activity was shown in vitro against
SARS-CoV-2 Alpha, Beta, Delta, Gamma and Omicron Variants of
Concern, adding to our existing in vitro studies which showed
potent antiviral activity against a wide variety of seasonal
respiratory and pandemic viruses including RSV, rhinovirus, various
influenza strains including H5N1, and MERS-CoV.
-- Undertook a thorough evaluation of clinical development
options to map out a route to conducting a Phase 3 registrational
programme required for a regulatory submission.
o Identified a clinical development plan for SNG001 designed to
address the unmet need in targeted, high-risk patient populations
that appear to be most responsive to SNG001 in previous clinical
trials, for example elderly patients and those with certain
co-morbidities.
o In addition, we plan to assess SNG001 in immunocompromised
patients who are particularly vulnerable to respiratory viral
infections, ventilated patients with confirmed viral pneumonia, and
also those who appear unable to clear virus and become long term
"shedders" and mutation hosts.
o Plan will start with a series of focused,
investigator-led/Synairgen-sponsored studies, using existing
resources, which are intended to lead towards a Phase 3
registrational programme. Preparation is underway for these focused
trials to initiate in H2 2023.
Financial
-- Loss from operations for the year ended 31 December 2022 of
GBP20.3 million (2021: GBP57.9 million), with R&D expenditure
decreasing to GBP14.9 million (2021: GBP52.9 million).
-- Cash and deposit balances of GBP19.7 million at 31 December
2022 (31 December 2021: GBP33.8 million).
Richard Marsden, CEO of Synairgen, said : "2022 was an
insightful year for Synairgen, pointing us towards a clear clinical
development plan following analysis of the Phase 3 SPRINTER data
and other important data.
"We confirmed with our clinical collaborators the significant
unmet need for broad-spectrum antivirals to help address both the
ongoing need to treat viral lung infections, and in preparation for
future pandemics. We believe that SNG001 has the potential to help
fill this important gap in respiratory treatments for high-risk
patient groups and we look forward to initiating the first trials
in the second half of this year."
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
Media@synairgen.com
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and Joint Broker)
Geoff Nash, Charlie Beeson (Corporate Finance)
Alice Lane, Sunil de Silva (ECM)
Tel: + 44 (0) 20 7220 0500
Numis Securities Limited (Joint Broker)
Freddie Barnfield, Duncan Monteith, Euan Brown
Tel: + 44 (0) 20 7260 1000
Consilium Strategic Communications (Financial Media and Investor
Relations)
Mary-Jane Elliott, Namrata Taak
cscsynairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5700
MKC STRATEGIES, LLC (US Media Relations)
Mary Conway
MConway@MKCStrategies.com
Tel: +1 516-606-6545
Notes for Editors
About Synairgen
Synairgen is a UK-based respiratory company focused on drug
discovery, development and commercialisation. The Company's primary
focus is developing SNG001 (inhaled interferon beta) for the
treatment of severe viral lung infections, including COVID-19, as
potentially the first host-targeted, broad-spectrum antiviral
treatment delivered directly into the lungs. SNG001 has been
granted Fast Track status from the US Food and Drug Administration
(FDA). Founded by University of Southampton Professors Sir Stephen
Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is
quoted on AIM (LSE: SNG). For more information about Synairgen,
please see www.synairgen.com .
CHAIRMAN'S STATEMENT
2022 started with high hopes for the success of our Phase 3
clinical trial of SNG001 for the treatment of COVID-19 in
hospitalised patients. Unfortunately, the trial did not meet its
primary endpoints, which was most likely due to improvements in
standards of care and is further discussed in this report. However,
the data did provide significant insights into the patient groups
that appeared to benefit most from SNG001. This has enabled
Synairgen to refocus on SNG001's potential both in the hospital and
the home environment as a broad-spectrum antiviral for those most
at risk of severe respiratory problems. This obviously includes
COVID-19, however the Group's work in 2022 has shown that there is
a significant unmet need in the broader respiratory antiviral area,
in addition to the need to find potential treatment solutions for
future viral pandemics. Respiratory virus infections remain a
leading cause of death globally.
Working closely with our partners, including academic
institutions, diagnostic and medical device companies, advisors,
and our strong team of researchers, scientists and regulatory
experts, and building on the substantial body of trial evidence we
have for SNG001, the team spent much of the year advancing the
clinical development plans to pursue this goal. These are in the
process of being discussed with potential trial sites and
investigators with a view to commencing later this year.
I would like to take this opportunity to thank the Board of
Directors for their unwavering support during this challenging
time. Their guidance and expertise have been invaluable in helping
us navigate both the challenges and analysis of the opportunities.
I would also like to note the retirement of Theo Harold and Iain
Buchanan, both of whom have made significant con tributions to
Synairgen. At the same time, we are pleased to welcome Amanda
Radford and Flic Gabbay to our Board of Directors. Their experience
and insight will be instrumental in helping us achieve our
goals.
I am proud of the dedication and hard work of our entire team in
a particularly challenging year, and I am excited for our future
progress in developing this novel treatment for a wide range of
viral respiratory diseases.
Simon Shaw
Chairman
OPERATIONAL REVIEW
Overview
2022 was an important year for Synairgen, providing the Group
with insights and data that have helped refine and clarify the
potential for SNG001.
In the first quarter of 2022 the Group received the
disappointing news that the Phase 3 SPRINTER trial of SNG001 in
hospitalised patients with COVID-19 did not meet the trial's
primary endpoints. Following the announcement of the topline
results, post hoc analyses subsequently showed positive trends in
subsets of higher risk patient groups within the trial. Through
this work and months of investigation, both in-house and with
clinical collaborators on both sides of the Atlantic, we have
established a number of ways forward for the SNG001 development
programme. We are embarking on these with renewed vigour in
2023.
From a clinical perspective, alongside the safety data
accumulated to date from the more than 750 patients dosed with
SNG001, we gained important new insights about the specific patient
populations to target in future clinical trials, particularly in
relation to the potential for reducing the risk of disease
progression - whether in the hospital setting or the home
environment. We can also see from the SPRINTER trial that SNG001
may have a positive effect in reducing the risk of several
recognised Long COVID symptoms. Finally, a further analysis during
the year of the SG015 Phase 2 trial in patients with COPD showed
accelerated viral clearance of human rhinovirus in patients
receiving SNG001 compared to placebo.
On the non-clinical side, we learned more about the mechanism of
action of SNG001 as a host directed, variant-agnostic antiviral
agent. Adding to our existing in vitro studies which showed potent
antiviral activity against a wide variety of seasonal respiratory
and pandemic viruses including RSV, rhinovirus, various influenza
strains including H5N1 and MERS-CoV, we showed potent antiviral
activity in further in vitro studies against SARS-CoV-2 Alpha,
Beta, Gamma, Delta and Omicron Variants of Concern. ([1])
The market context is clear: there are no approved antiviral
therapies for the majority of hospitalised adult patients due to
respiratory viral lung infections, and the pandemic has highlighted
the significant issues for health systems and patients as a result.
In the US alone, approximately three million people are
hospitalised every year due to viral lung infections such as
rhinovirus, Respiratory Syncytial Virus (RSV), COVID-19, influenza
and others. ([2])
Our work in 2022 has shown that there is a significant unmet
need in this broader antiviral area, in addition to the need to
find potential treatment solutions for future viral pandemics. Our
clinical work over many trials to date indicates that SNG001 has
potential utility against a wide spectrum of respiratory viruses in
certain high-risk patient groups.
Development Plan
This accumulated non-clinical and clinical data, together with
third party research and feedback from the clinical community, has
strengthened our conviction that SNG001 has potential as a
broad-spectrum antiviral which could be directed towards certain
types of patients infected with a wide range of respiratory
viruses. The Synairgen team, and our collaborators and advisors,
have assessed many different options for an optimal clinical
development programme, and have mapped out a series of focused
clinical trials to confirm the signals we have seen and investigate
SNG001 against this wide spectrum of respiratory viruses in
specific high-risk patient groups.
Mindful of the insights gained in 2022 and the challenges
outlined, Synairgen continues to explore the potential of SNG001 in
three settings:
-- For use as a broad-spectrum antiviral in people hospitalised
with severe viral lung infections, particularly those in high-risk
groups;
-- To prevent progression of disease/hospitalisation in
high-risk patient groups with a range of respiratory viruses in the
home setting; and
-- As a possible future pandemic preparedness option for government agencies.
We are now progressing protocols specific to three main
opportunities for the next stage of the development programme,
namely in the patient populations identified: in the elderly (who
were most at risk during the pandemic); immunocompromised (such as
patients taking chemotherapy for whom even a common cold can delay
effective treatment of their underlying disease); and other
patients who may benefit most from the use of SNG001 (including
ventilated patients with confirmed viral pneumonia and those who
appear unable to clear virus and become long term "shedders" and
mutation hosts). Both individually and collectively, these are
significant unaddressed market opportunities.
Clinical Development Outlook
The Group and its clinical advisors believe that based on the
safety data and body of pre-clinical and clinical data for SNG001
it has the potential to be the first inhaled broad-spectrum
antiviral for the patients who are at high risk of disease
progression.
The development of a broad-spectrum antiviral treatment has been
a significant challenge in the field of antiviral research. The
search for a broad-spectrum antiviral treatment can be traced back
several decades, with a growing recognition of the need for a
treatment that can effectively target a wide range of different
viral infections.
In recent years, there has been increased recognition in the
importance of developing broad-spectrum antivirals that target the
host cell rather than the virus itself. However, despite this
growing interest, there is currently no precedent for a
broad-spectrum antiviral clinical development programme.
Many of the platform trials that emerged during the COVID-19
pandemic have completed or wound down in part due to lower rates of
severe illness or changes in funding. Synairgen has been and
remains in contact with the relevant platform trial investigators
and will continue to evaluate options should they arise; however,
in parallel, wanting to move forward at pace, we believe that
implementing our own current clinical development plan as quickly
as possible will provide promising opportunities to collect
appropriate and meaningful data to support an eventual regulatory
submission.
Over the past year, the Group has undertaken a thorough
evaluation of clinical development options with the aim of
conducting a Phase 3 registrational programme required for a
regulatory submission. As there is no precedent for a
broad-spectrum antiviral clinical development programme, designing
and determining a clinical pathway is complex as there are multiple
viruses being targeted for different high-risk patient groups. It
has been determined that to achieve this aim, a multi-staged
clinical development plan is required.
The Group is now advancing a clinical development plan for
SNG001 designed to address the unmet need in targeted patient
populations that appear to be most responsive to SNG001 in previous
clinical trials, as well as in immunocompromised patients who are
particularly vulnerable to respiratory viral infections, and also
ventilated patients with confirmed viral pneumonia. This plan will
start with a series of focused,
investigator-led/Synairgen-sponsored studies that build a pathway
towards a Phase 3 registrational programme. Preparation is underway
for these focused trials to initiate in H2 2023.
Clinical Need
Severe viral lung infections can be caused by a variety of
viruses, including influenza, coronaviruses, RSV, rhinovirus, and
adenovirus, among others. These infections can lead to serious
complications, including pneumonia, acute respiratory distress
syndrome (ARDS), and death, particularly in vulnerable populations
such as elderly individuals, those with COPD and asthma, and people
with weakened immune systems.
In the US, severe viral lung infections are responsible for
upwards of three million hospitalisations annually, at a cost of
$50 billion. ([3])
Current antiviral treatments are limited in their efficacy, as
they are typically specific to a single virus. For example, while
certain antivirals are effective against influenza, they are not
effective against other viruses that can cause severe lung
infections, such as coronaviruses or RSV.
This highlights the need for a broad-spectrum antiviral that can
effectively treat a range of different viral lung infections,
regardless of the specific virus causing the infection. A
broad-spectrum antiviral would be a valuable addition to the
healthcare arsenal, as it would improve outcomes for patients and
reduce the spread of viral infections in healthcare settings.
Additionally, a broad-spectrum antiviral would be useful in the
event of a pandemic caused by a novel virus, as it would provide a
treatment option even if the aetiology of the specific virus is not
yet known.
In summary, the need for a broad-spectrum antiviral to treat
severe viral lung infections is driven by the high incidence of
severe lung infections caused by a variety of different viruses,
the limited number and efficacy of current antivirals, and the
potential to improve outcomes for patients and reduce the spread of
viral infections.
The annual cost of hospitalisations for severe lung infections
illustrates the substantial market opportunity for an effective
broad-spectrum antiviral to treat such infections.
Rationale for SNG001 as a broad-spectrum antiviral
There is a strong scientific rationale underpinning SNG001 for
use in treating patients infected with a broad range of respiratory
viruses, combined with its safety profile and a growing body of
encouraging clinical and non-clinical data which has helped us
better understand the potential role SNG001 might play in treating
patients at risk of developing severe illness due to these
respiratory viruses.
The Group has conducted in vitro testing of SNG001 against a
broad range of respiratory viruses ranging from seasonal cold and
flu viruses like RSV and rhinovirus; highly pathogenic viruses such
as H5N1, a form of 'bird flu', MERS-CoV, SARS-CoV-2 variants of
concern including Alpha, Beta, Gamma, Delta and Omicron. ([4]) In
vitro tests have shown potent antiviral activity at concentrations
that are readily achievable following inhaled delivery of
interferon beta. We believe these concentrations could not be
accomplished at the lining of the lungs via the injected route, and
indeed recent studies have shown systemic use of IFN-B through
injection is ineffective in fighting COVID-19 in the lungs.
([5])
2022 Clinical Summary and Progress
SPRINTER - Investigating SNG001 in the hospitalised
environment
SPRINTER (SG018; NCT04732949) was a global, randomised,
placebo-controlled, double-blind clinical trial assessing the
efficacy and safety of inhaled SNG001 for the treatment of adults
hospitalised due to COVID-19 who required treatment with
supplemental oxygen. The trial recruited a total of 623 patients
who were randomised to receive SNG001 (n=309) or placebo (n=314) on
top of standard of care.
Synairgen announced in February 2022 that the Phase 3 SPRINTER
trial did not meet the primary endpoints of discharge from hospital
and recovery. There was, however, an encouraging signal in the key
secondary endpoint of reduction in the relative risk (RRR) of
progression to severe disease or death within 35 days including a
25.7% reduction in the Intention-to-Treat population and 36.3%
reduction in the Per Protocol population (though neither was
statistically significant).
To assess the strength of this signal and identify specific
patient populations that might benefit most from treatment, post
hoc analyses were performed on groups of patients recognised to be
at greater risk of developing severe disease in hospital. These
analyses included patients >=65 years old, those with
co-morbidities associated with worse COVID-19 outcomes and those
who, at baseline, despite receiving low flow oxygen, had clinical
signs of compromised respiratory function (defined as oxygen
saturation of <= 92% or respiratory rate >= 21
breaths/min).
These analyses showed stronger treatment effects with SNG001 in
high-risk patient subgroups, with the strongest effect observed in
those who had clinical signs of compromised respiratory function.
In these patients, who represented approximately one-third of the
SPRINTER trial population, SNG001 significantly reduced the risk of
progression to severe disease or death compared to placebo by 70%
in the Per Protocol population (Odds Ratio (95% Confidence
Interval) 0.23 (0.06, 0.98); p=0.046).
The data from this pivotal trial was presented at the Clinical
Trials Symposium of the American Thoracic Society 2022 (ATS 2022)
International Conference in San Francisco, California in May 2022
and appeared in the peer-reviewed European Respiratory Journal Open
Research (ERJOR) in December 2022.
In addition to this, Long COVID symptoms and patient reported
outcome measures were assessed as a secondary endpoint of the
SPRINTER trial at follow-up visits via telephone/video call on Day
60 and 90. Patients on SNG001 saw the relative risk of
fatigue/malaise reduced [RRR=35.4%], one of the most common
symptoms of Long COVID.
ACTIV-2 - Investigating antiviral treatments in the home
environment
In October 2022, Synairgen received the positive topline results
for outcomes through 28 days of follow-up from the Phase 2
evaluation of SNG001 from the US National Institute of Allergy and
Infectious Diseases (NIAID) ACTIV-2 trial (Protocol ACTIV-2/A5401:
"Adaptive Platform Treatment Trial for Outpatients with COVID-19
[Adapt out COVID]"; Appendix B). This trial was established to
investigate potential therapies in adults experiencing mild to
moderate COVID-19 outside of the hospital setting. Based on the
study results, the Independent Data Safety Monitoring Board for
ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 but in
March 2022, the NIH decided to halt all participant recruitment in
the trial due to the significant shift in the nature of the
pandemic. At that point, the Phase 3 component, including SNG001,
was halted.
Overall SNG001 was well-tolerated and there was no statistically
significant difference between SNG001 and placebo with respect to
the primary safety outcome measure, and there were no statistically
significant differences in the other primary outcomes namely time
to symptom improvement or viral clearance. It is notable that one
patient was hospitalised in the SNG001 treatment group compared
with seven in the Placebo group (1/110 SNG001 versus 7/110 placebo,
representing an 86% relative risk reduction p=0.07). While the
Phase 2 stage of the trial was not powered to prove this, the
promising decrease in hospitalisations in patients that received
SNG001 may be important, especially combined with a good safety
profile.
The data from the ACTIV-2 trial was presented at the Conference
on Retroviruses and Opportunistic Infections Conference (CROI) in
February 2023 by Dr William Fischer from the University of North
Carolina at Chapel Hill and have been submitted for publication in
a peer-reviewed journal.
To build on the results of the ACTIV-2 trial, one of the
clinical opportunities we are investigating for SNG001 is its use
in the home environment to help prevent hospitalisation in
high-risk patients with a wide range of viral lung infections.
SG015 COPD trial virology
In early 2020, due to the emergence of SARS-CoV-2, Synairgen's
SG015 (NCT03570359) trial in COPD patients was paused with 109 out
of the targeted 120 patients recruited. An interim analysis of the
data was reported in September 2020 which demonstrated that SNG001
boosted lung antiviral responses as assessed using sputum
biomarkers and a significant improvement in the lung function of
exacerbating patients.
In September 2022, Synairgen reported positive data from post
hoc assessments of lung sputum samples from SG015 which showed that
SNG001 accelerated clearance of rhinovirus (which approximately
half of the trial participants had) from the lungs. This builds on
existing data supporting SNG001's mechanism of action.
Manufacturing
As we look ahead to delivering the clinical development
programme, we have made the strategic decision to focus our
manufacturing efforts on the supply of additional pre-filled
syringe drug product and placebo for clinical trials. While we
remain committed to exploring new packaging options, such as
blow-filled sealed delivery, we believe that at this time it is
important to prioritise the production of SNG001 to fulfil current
requirements, using current proven process and materials.
FINANCIAL REVIEW
Consolidated Statement of Comprehensive Income
The loss from operations for the year ended 31 December 2022 was
GBP20.3 million (2021: GBP57.9 million loss) with research and
development expenditure amounting to GBP14.9 million (2021: GBP52.9
million) and other administrative expenses of GBP5.4 million (2021:
GBP5.0 million).
Research and development expenditure continued to be focussed on
clinical trials and manufacturing activities.
Clinical trial expenditure on SPRINTER, SG015 and SG016 reduced
markedly compared to 2021. Additional preparatory costs for the
ACTIV-2 Phase 3 study were incurred in 2022 prior to the trial
being halted.
Manufacturing activities (including procurement of long lead
time items) also reduced significantly in 2022 with the main area
of expenditure being on outsourced activities, including blow fill
seal drug product development, release testing, stability testing
and comparison testing, with all costs being expensed to the income
statement.
Other administrative expenses, which comprises all expenses
which are not research and development expenditure, of GBP5.4
million in 2022 remained broadly in line with the total expenditure
of GBP5.0 million in 2021. There was greater expenditure on medical
affairs and corporate communications in 2022 compared to 2021 when
there was a greater expenditure on pre-commercialisation
activities.
Interest receivable increased from GBPnil to GBP0.2 million as
deposit interest rates increased during the second half of
2022.
The research and development tax credit decreased from GBP9.2
million to GBP2.4 million in line with reduced qualifying research
and development expenditure. The credit equates to 16% of our 2022
research and development expenditure (2021: 17%).
The loss after tax for 2022 was GBP17.6 million (2021: GBP48.7
million) and the basic loss per share was 8.76p (2021: basic loss
per share of 24.28p).
Consolidated Statement of Financial Position and Cash Flows
At 31 December 2022, net assets amounted to GBP20.3 million
(2021: GBP37.0 million), including cash and deposit balances of
GBP19.7 million, comprising cash and cash equivalents of GBP15.9
million and other financial assets - bank deposits of GBP3.8
million, (2021: GBP33.8 million cash and cash equivalents).
The principal elements of the GBP14.1 million decrease during
the year ended 31 December 2022 (2021: GBP41.2 million decrease) in
cash and deposit balances were:
-- Cash outflows from operations before changes in working
capital: GBP19.3 million (2021: GBP57.2 million), with the
reduction being attributable to the lower research and development
expenditure as explained above;
-- Changes in working capital: GBP4.1 million outflow (2021:
GBP12.2 million inflow), on account of the reduction in trade and
other payables as discussed below. In 2021 there was a reduction in
trade and other receivables of some GBP7.8 million and an increase
in trade and other payables of GBP4.4 million;
-- Interest received GBP0.1 million (2021: GBPnil); and
-- Research and development tax credits received: GBP9.1 million
(2021: GBP3.9 million) on account of receipt of the 2021 tax
credit.
The other significant changes in the Statement of Financial
Position were:
-- Current tax receivable decreased from GBP9.1 million to
GBP2.4 million on account of the lower research and development tax
credit receivable; and
-- Trade and other payables decreased from GBP7.6 million to
GBP3.3 million as trade payables reduced from GBP4.2 million to
GBP0.5 million in line with the reduction in the level of operating
expenditure.
OUTLOOK
Underpinned by the encouraging data accumulated to date for
SNG001 and that respiratory virus infections remain a leading cause
of death globally, we remain excited by its potential to be the
first inhaled broad-spectrum antiviral for patients at high risk of
disease progression, in both the hospital and home environment.
Based on the significant clinical need and the insights gained
from our clinical and pre-clinical data, the Group will advance its
clinical development plan for SNG001 with a series of focused,
investigator-led/Synairgen-sponsored studies, commencing in H2 2023
utilising existing cash resources, to build a pathway towards a
Phase 3 registrational programme.
We continue to gather valuable insights from studies conducted
and look forward to presenting our latest analysis of the Phase 3
SPRINTER trial data at ISIRV and ATS in May and updating all our
shareholders on our progress in due course.
Consolidated Statement of Comprehensive Income
for the year ended 31 December 2022
Year Year
ended 31 ended 31
December December
2022 2021
Notes GBP000 GBP000
Research and development expenditure (14,936) (52,857)
Other administrative expenses (5,364) (5,009)
-------------------------------------- ------ ------------------- -------------------
Total administrative expenses
and Loss from operations (20,300) (57,866)
Finance income 207 11
Finance expense - (2)
Loss before tax (20,093) (57,857)
Tax 2 2,448 9,194
Loss and total comprehensive
loss for the period attributable
to equity holders of the parent (17,645) (48,663)
=================== ===================
Loss per ordinary share 3
Basic and diluted loss per share
(pence) (8.76)p (24.28)p
Consolidated Statement of Changes in Equity
for the year ended 31 December 2022
Merger Retained
Share capital Share premium reserve deficit Total
GBP000 GBP000 GBP000 GBP000 GBP000
At 1 January 2021 1,999 125,245 483 (42,586) 85,141
------------- ------------- -------- --------- --------
Loss and total comprehensive
loss for the year - - - (48,663) (48,663)
------------- ------------- -------- --------- --------
Transactions with equity
holders of the Group
Issue of ordinary shares 14 - - - 14
Recognition of share-based
payments - - - 508 508
------------- ------------- -------- --------- --------
14 - - 508 522
------------- ------------- -------- --------- --------
At 31 December 2021 2,013 125,245 483 (90,741) 37,000
------------- ------------- -------- --------- --------
Loss and total comprehensive
loss for the year - - - (17,645) (17,645)
------------- ------------- -------- --------- --------
Transactions with equity
holders of the Group
Issue of ordinary shares 1 - - - 1
Recognition of share-based
payments - - - 919 919
------------- ------------- -------- --------- --------
1 - - 919 920
------------- ------------- -------- --------- --------
At 31 December 2022 2,014 125,245 483 (107,467) 20,275
============= ============= ======== ========= ========
Consolidated Statement of Financial Position
as at 31 December 2022
31 31
December December
2022 2021
GBP000 GBP000
Assets
Non-current assets
Intangible assets 44 53
Property, plant and equipment 86 173
Right-of-use assets - -
---------------------- ---------------
130 226
---------------------- ---------------
Current assets
Current tax receivable 2,415 9,055
Trade and other receivables 1,308 1,530
Other financial assets - bank deposits 3,750 -
Cash and cash equivalents 15,926 33,827
---------------------- ---------------
23,399 44,412
Total assets 23,529 44,638
---------------------- ---------------
Liabilities
Current liabilities
Trade and other payables (3,254) (7,638)
Total liabilities (3,254) (7,638)
---------------------- ---------------
Total net assets 20,275 37,000
====================== ===============
Equity
Capital and reserves attributable
to equity holders of the parent
Share capital 2,014 2,013
Share premium 125,245 125,245
Merger reserve 483 483
Retained deficit (107,467) (90,741)
---------------------- ---------------
Total equity 20,275 37,000 )
====================== ===============
Consolidated Statement of Cash Flows
for the year ended 31 December 2022
Year Year
ended 31 ended 31
December December
2022 2021
GBP000 GBP000
Cash flows from operating activities
Loss before tax (20,093) (57,857)
Adjustments for:
Finance income (207) (11)
Finance expense - 2
Lease adjustment - (4)
Depreciation of property, plant and equipment 93 92
Depreciation of right-of-use assets - 94
Amortisation of intangible fixed assets 9 9
Share-based payment charge 919 508
--------- ---------
Cash flows from operations before changes
in working capital (19,279) (57,167)
Decrease in inventories - 41
Decrease in trade and other receivables 289 7,841
(Decrease)/Increase in trade and other
payables (4,384) 4,359
--------- ---------
Cash used in operations (23,374) (44,926)
Tax credit received 9,088 3,910
--------- ---------
Net cash used in operating activities (14,286) (41,016)
--------- ---------
Cash flows from investing activities
Interest received 140 12
Purchase of intangible assets - (18)
Purchase of property, plant and equipment (6) (15)
Increase in other financial assets (3,750) -
Net cash used in investing activities (3,616) (21)
--------- ---------
Cash flows from financing activities
Proceeds from issue of ordinary shares 1 14
Principal paid on lease liabilities - (124)
Interest paid on lease liabilities - (2)
Net cash generated from/(used in) financing
activities 1 (112)
--------- ---------
Decrease in cash and cash equivalents (17,901) (41,149)
Cash and cash equivalents at beginning
of the year 33,827 74,976
--------- ---------
Cash and cash equivalents at end of the
year 15,926 33,827
========= =========
Notes
1. Basis of preparation
The financial information of the Group set out above does not
constitute "statutory accounts" for the purposes of Section 435 of
the Companies Act 2006. The financial information for the year
ended 31 December 2022 has been extracted from the Group's audited
financial statements which were approved by the Board of directors
on 26 April 2023 and will be delivered to the Registrar of
Companies for England and Wales in due course. The financial
information for the year ended 31 December 2021 has been extracted
from the Group's audited financial statements for that period which
have been delivered to the Registrar of Companies for England and
Wales. The reports of the auditors on both these financial
statements were unqualified, did not include any references to any
matters to which the auditors drew attention by way of emphasis
without qualifying their report and did not contain a statement
under Section 498(2) or Section 498(3) of the Companies Act 2006.
While the financial information included in this preliminary
announcement has been prepared in accordance with the recognition
and measurement criteria of UK adopted International Financial
Reporting Standards ('IFRSs'), this announcement does not itself
contain sufficient information to comply with those IFRSs. This
financial information has been prepared in accordance with the
accounting policies set out in the December 2022 report and
financial statements.
2. Tax
The tax credit of GBP2,448,000 (2021: GBP9,194,000) relates to
research and development tax credits in respect of the year ended
31 December 2022 (GBP2,415,000) and an adjustment in respect of
prior periods (GBP33,000).
3. Loss per ordinary share
Basic loss per share is calculated by dividing the loss
attributable to ordinary equity holders of the parent company by
the weighted average number of ordinary shares in issue during the
year.
The loss attributable to ordinary shareholders and weighted
average number of ordinary shares for the purpose of calculating
the diluted earnings per ordinary share are identical to those used
for basic loss per share. This is because the exercise of share
options would have the effect of reducing the loss per ordinary
share and is therefore antidilutive under the terms of IAS 33.
[1] Synairgen on file.
[2] IQVIA market research Q4 2022; Sources: US CDC, HCUP, IQVIA
Claims Data, PubMed; data on file.
[3] Hartnett J. Influenza Other Respir Viruses. 2022;16:906-915;
Pastula ST et.al.,OFID, 2017, ofw270; Zhou JA et.al., CID, 2020,
70(5): 773-779; Disease Burden of Flu | CDC; Preliminary Medicare
COVID-19 Data Snapshot (Dec 2021); ICER Report: Special Assessment
of Outpatient Treatments for COVID-19 (Feb 2022).
[4] Synairgen on file.
[5] WHO Solidarity Trial Consortium. Repurposed Antiviral Drugs
for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med.
2021;384:497-511.
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END
FR DBGDSIBDDGXL
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April 27, 2023 02:00 ET (06:00 GMT)
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